Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)

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Brief Title

Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)

Official Title

Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

Brief Summary

      Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to
      histopathological risk factors of the International Retinoblastoma Staging Working Group.
    

Detailed Description

      Post operative chemotherapy +/- radiotherapy according to histopathological risk factors of
      the International Retinoblastoma Staging Working Group.

        -  Low risk group :

             -  No optic nerve involvement.

             -  Intra and prelaminar involvement

             -  No choroidal involvement.

             -  Minimal superficial choroidal involvement .

        -  Intermediate risk group, 2 sub groups :

             -  Sub group 1 :

                  -  Retrolaminar involvement without Invasion of surgical margin associated or not
                     to massive choroidal involvement

                  -  Anterior segment involvement.

                  -  Intrascleral involvement.

             -  Sub Group 2 :

                  -  Isolated massive choroidal involvement.

        -  High risk group :

             -  Invasion of the surgical margin of the optic nerve

             -  and/or microscopic extrascleral involvement

             -  Optic nerve meningeal sheat involvement .
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of extra ocular relapses

Secondary Outcome

 Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary.

Condition

Retinoblastoma

Intervention

Observation

Study Arms / Comparison Groups

 Low risk group
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

185

Start Date

March 2010

Completion Date

September 2029

Primary Completion Date

March 2029

Eligibility Criteria

        Inclusion Criteria:

          1. Written informed consent - a signed informed consent and/or assent (as age
             appropriate) will be obtained according to institutional guidelines;

          2. Male or female ≥2 months and <10 years of age at the time of signing the informed
             consent form;

          3. Diagnosis of non familial extensive unilateral retinoblastoma treated by primary
             enucleation

          4. In case of post operative chemotherapy, patients must have adequate organ function:

               -  Adequate hematopoietic function Neutrophils>1.0x109/l, Platelets >100 x 109/l.

               -  Adequate hepatic function: grade II NCI CTC

               -  Adequate renal function: serum creatinemia <1.5 x ULN for age with normal
                  creatinine clearance estimated by SCHWARTZ formula

               -  Audiometry < Grade II de Brock.

               -  Echocardiography normal in case of high dose cyclophosphamide chemotherapy (3
                  g/m²).

          5. Patients affiliated to a Social Security Regimen or beneficiary of the same

          6. No chemotherapy or radiotherapy prior to administration of the first dose of study
             treatment for retinoblastoma or other tumor types

          7. Without medical cons-indication to study drugs.

        Exclusion Criteria:

          -  Bilateral and/or familial or trilateral retinoblastoma.

          -  Unilateral retinoblastoma with indication of primary chemotherapy before enucleation:

               -  One or several surgical risk factors

               -  Buphthalmia Exophthalmia.

               -  Peri ocular inflammatory signs.

               -  Extraocular extension :

               -  Radiological retrolaminar extension (more than 3 mm behind the lamina cribrosa)
                  and or meningeal sheat optic nerve extension.

               -  Extrascleral extension

               -  Lymp nodes extension

          -  Unilateral retinoblastoma with possibility of conservative treatment:

          -  Metastatic extension at diagnosis

          -  One inclusion criteria non observed

          -  Uncontrolled medical conditions, psychological, familial, sociological, or
             geographical conditions that do not permit compliance with the protocol
      

Gender

All

Ages

2 Months - 10 Years

Accepts Healthy Volunteers

No

Contacts

, , [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02870907

Organization ID

IC 2009-04 RB SFCE 09


Responsible Party

Sponsor

Study Sponsor

Institut Curie


Study Sponsor

, , 


Verification Date

August 2020